An examination of a catalog of a catheter manufacturing company, such as the Product Catalog of the Bard Medical Division (Bard Medical Division, 8195 Industrial Boulevard, Covington, Ga. 30014-2655) indicates the very wide array of sizes, types, as well as diameters of various catheters or drainage devices and related products that are utilized by insertion of such devices into humans or animals. Since many of the wound drainage devices and catheter devices may remain so inserted into the body for extended periods of time, it has become necessary to affix the catheter at the point of insertion in order to ensure its retention at the site of insertion and also to provide and deliver antimicrobial activity to the insertion site since the piercing of the skin frequently can result in a site of microbial entrance and infection.
A typical device that has hereto been developed for such purpose is described in U.S. Pat. No. 5,833,665 invented by Bootman et al. Because of the great variability of the diameter of various catheters and also needles that are inserted into the body to which catheters may be a part, it would be desirable that the catheter patch be prepared in a manner, which would lend itself to utilization with a relatively wide variety of diameters of catheters. This would obviate the necessity of preparing different size patches for different size catheters and related devices. It is therefore an object of the present invention, to develop a catheter patch that has an adjustable center that would fit over the catheter and that said configuration would be applicable for use for a wide variety of diameters of a catheter.
The invention of Winnie (U.S. Pat. No. 4,040,427), describes a device that is intended for use with catheters and related devices. The utility of a series of slits emanating from a small central opening in the instant application provides the versatility of the patch to be used with a wider range of diameters of catheters and related devices than could be utilized by the invention of Winnie. If larger catheters are required for different applications, Winnie's invention would mandate that a series of different size diameters as shown in FIG. 1 of Winnie's patent, labeled 32 would be necessary to accommodate different size diameters of catheters. Whereas, in the instant application, the small slits around the central opening can give way to accommodate a much wider series of diameters without having to design a different patch for each diameter. Therefore, the utility of these slits, which nowhere appear in the Winnie patent provide a utility, which also provides novelty for the instant design submitted herein.
There is another attribute of the instant application of Scherr, which is not addressed by the Winnie patent, and that concerns the utilization of a patch which when placed next to the skin of a patient into which a catheter has been inserted, that the constitution of the patch placed against the opening will have an antimicrobial activity in the event that exudate will begin to appear at the cite of injection. Such infections have been known in the past and in fact can be very dangerous. Thus chlorhexidine-impregnated patches used for similar purposes as described in the instant application have been shown to have nosocomial Pseudomonas cepacia infections associated with chlorhexidine contaminations (Am. J. Med.; VOL 73 ISS August 1982, P 183-186). The cycloheximide patch also had the undesirable attribute of resulting in anaphylactic reactions, (United States Food and Drug Administration, FDA Public Health Notice dated Mar. 11, 1998, entitled POTENTIAL HYPERSENSITIVITY REACTIONS TO CHLORHEXIDINE-IMPREGNATED MEDICAL DEVICES) an attribute not present in the constitution of the material from which the patches described herein are made. It is for these reasons that applicant has taken the pains to indicate the composition of the material from which the patch is prepared and the antimicrobial activity which the patch has been shown to contain. Data for this can be found in the 510(k) application with the United States Food and Drug Administration, which application (United States Food and Drug application K011618) has been approved for this composition, and which constitutes one preferred composition of the patch of the instant application.
The invention of Ignotz, et al. (U.S. Pat. No. D488,230), is an infusion adhesive patch that has three openings with an enclosed perimeter around the three openings of the patch. Consequently, the patch would have to be applied to the skin of the patient before a needle and the inclusive catheter is inserted through one of the openings of the patch. Should it happen that the veins are not readily available to the entrance of the needle and the medical attendant would have to find another site of injection into a vein, then the patch would have to be removed from the initial site and transferred to a secondary site before the insertion of a needle through one of the openings of the patch. In the instant invention of applicant, the patch permits itself to be placed over the needle and/or over entrance of the catheter after insertion of a needle attached to a catheter has been achieved (emphasis added). If it is necessary for the medical attendant to try one or two injection sites before succeeding, it is no deterrent to the patch being placed over the entrance of the catheter and adhere it to the entrance site against the skin where it can be fixed in place with adhesive. This is a significant attribute of the instant application described herein which is totally lacking in the patent of Ignotz, et al. and therefore the novelty of the instant application has no counterpart in the invention of Ignotz, et al.
The invention of Foerster (U.S. Pat. No. D265,128) describes a protective mammary bandage. The slit in this bandage permits the bandage to be formed and sealed up with a tape so that it will fit over a breast. The central opening obviously, is for the woman's nipple.
In use, the slit in the Foerster device and the hole opening in the center of the Foerster device play absolutely no role that in any way could be construed as being applicable for use with a catheter. In addition, the mammary bandage of Foerster lacks the slits that would make it feasible to fit over a woman's breast if there was consideration required for the size of the woman's nipples of the breast. The Foerster device is not amenable for use for a wider array of sizes of breast nipples or for different diameter catheters, if in fact the Foerster device were intended for and could even be used as a patch for a catheter or related device. Consequently, there is no prior art in the Foerster device that is relative to the device in the instant application.
The subject of Houser et al.'s patent, (U.S. Pat. No. 6,241,715 B1), is also a breast pad which, similar to the Foerster mammary bandage, contains a slit leading to a central opening so that the slit can permit the form of the device to be contoured around the woman's breast leaving the central opening open for the nipple of the breast.
All of the commentary we have submitted above relative to the Foerster device is applicable to the Houser, et al. device and is repeated here by reference.
The device of Plass et al. (U.S. Pat. No. 5,232,453), essentially is very much similar to the device of Winnie (U.S. Pat. No. 4,040,427) except that the former has the proviso of providing adhesive strips, which may be attached to a catheter, that is passed through the opening of the device of Plass et al. as illustrated by the opening of number 42 in FIG. 3 of Plass et al's patent. Otherwise, the central opening in the Plass et al. patent number 42 is fixed as occurs in the patent of Winnie. The slit labeled number 46 in FIG. 3 of the device of Plass et al. is essentially the slit of Winnie's device except that the slit is in the form of a narrow angular quadrant labeled number 28 in FIG. 1 of the Winnie patent.
The Plass et al. patent will accommodate a diameter of a catheter depending upon the diameter of the opening in the center of the catheter holder and Plass et al. recognizes this restraint in that he sets forth in his patent that:                “The hole 42 may be about 7.5 mm in diameter, or such other value as may accommodate the required catheter, . . . . ”        
Obviously, for each different size of diameter of a catheter to be utilized, the Plass et al. patent would have to manufacture a device having a different diameter opening to accommodate the catheter, a totally unnecessary attribute that our invention circumvents by placing a number of slits emanating from the central opening of the catheter patch in our instant device.
The patent of Hesketh (U.S. Pat. No. 4,874,380), provides a central opening (Number 12 in FIG. 4 of Hesketh's patent) which is overly large. Hesketh, himself, indicates that the opening is such that it can accommodate catheters of an outside diameter from 2 mm to 10 mm:                “With this arrangement, irrespective of whether a catheter of outside diameter 10 mm or more, or a small catheter of outside diameter of 2 or 3 mm is employed, one can achieve a satisfactory clamping of the catheter without an undesired deformation of its wall and occlusion of its internal passage.”        
In order that the catheter, which is illustrated in FIG. 4 by the number 34, is affixed and will not move around, Hesketh has designed a locking mechanism (Item 22 in his FIG. 4) which locking mechanism will lock the catheter in place to the dressing and is composed of a ratchet and locking mechanism, which is adjusted depending upon the diameter of the catheter that is used. By this devise, relatively small catheters as is demonstrated in Hesketh's FIG. 4, still leave an opening (Number 12 in FIG. 4) which is open to the outside and does not represent a closed dressing in the area of the entrance to the body.
Consequently, the mechanism that Hesketh uses is in contrast to the multiple slit mechanism of the instant patent of Scherr in which the slits emanating from the central portion of the catheter patch permit a relatively wide array of diameters to be inserted through the patch without leaving a clear opening which is exposed to air, so exposing the entrance into the body to possible outside contamination.
Further, in order for the Hesketh device to maintain a fixed catheter it is necessary for the ratchet device to be attached to a component labeled Number 10 in FIG. 4, which is then separately adhered to the basic patch labeled Number 14 in FIG. 4 of the Hesketh patent. Consequently, there is little relationship between the basic novelty inherent in the Hesketh patent and that of the instant application of Scherr.
The U.S. Pat. No. 4,579,120 of MacGregor shows a slit emanating from the outside of the device to the central portion of the device as shown in FIG. 4 in the MacGregor patent, but there are no slits as is shown in FIGS. 1 and 2 of the MacGregor device to compensate for differences in diameter of a catheter as shown in the instant application. The passage 26 as shown in FIGS. 2 and 4, utilizes a cross section which is equal to the diameter of whatever electrical lead or catheter is inserted through the opening number 26, as is clearly set forth by MacGregor in his specification:                “With the exception of the flare 28, the passage 26 is of substantially constant cross-section over its length. The cross-sectional shape of the passage is substantially identical to the cross-sectional shape of the lead L and the diameter of the passage 26 is sized so that it snugly fits the lead L when the lead is inserted through the passage as shown in FIG. 1.”        
Even in the device as illustrated in FIG. 4 of the MacGregor patent, the slit makes it possible to insert the device over a protruding lead from the body, which lead is then moved into the passage 26 and whatever lead is protruding from the passage 26, as shown in FIG. 4 of the MacGregor patent, the portion 22 is then tied tightly to ensure that the lead (L) snugly fits into the passage 26. Thus, MacGregor points out that:                “Once the lead has been positioned, the other end of the lead outside of the body is inserted upwardly through the passage 26 via needle N and the disc 10 is slid downwardly along the lead until it contacts the skin of the patient and conforms to the curvature of the patient's skin surface at the exit location. At this point, the disc 10 and its surface 12 are adhered to the body at the lead exit location with the adhesive layer 14 to anchor the disc 10 and the lead L firmly to the body. The lead L, which is also of substantially constant cross-section over its length, fits snugly in the passage 26.        The lead is preferably further secured by tying or binding with a suitable thread-like member, such as a suture 30, about the stem portion 22 of the bulbous shaped head 20, as shown in FIG. 1. Tying with the suture 30 not only seals the passage 26 against the entry of contaminants to protect against infection, but also firmly secures the lead L in the passage 26 against sliding or other displacement. Although a suture 30 is shown about the stem portion 22, it will be understood that other forms of fixation may be employed, such as a clamp, clip, applied adhesive, elastic band, etc.”        
Consequently, each device of MacGregor has to be manufactured separately to accommodate the specific diameter of an electric lead or catheter that is either emanating from the body of a patient or is to be inserted into the body of a patient; unlike the latitude provided in the instant device of Scherr, in which one device with a series of slits emanating from a central opening permits a rather wide latitude of cross-sectional diameters to be inserted therein.
Because many catheters may be inserted into an appropriate part of the body and remain there for extended periods of time, it would be desirable that the site of insertion of any needle or similar device penetrating the body, be maintained in an environment that enhances antimicrobial activity to avoid bacterial contamination at that site. It is therefore one object of the invention that it would lend itself to being die cut or punched from a variety of prepared sheets that would contain antimicrobial activity for extended periods of time.
Since the maintenance of an inserted catheter may result in some tissue exudate being released from the site of the wound where the catheter enters the body, the catheter patch so utilized would benefit from having the capability to absorb such exudate. It is therefore another object of the instant invention of the catheter patch that would lend itself to being punched or die cut from various compositions and retain a significant level of absorption of any exudate that is released at the site of insertion of the catheter.